Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD) (GLOW3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01154127
First received: June 29, 2010
Last updated: April 10, 2012
Last verified: April 2012
Results First Received: February 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: NVA237
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NVA237 Followed by Placebo

Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Placebo Followed by NVA237

Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days

Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.


Participant Flow for 3 periods

Period 1:   Period 1 (21 Days)
    NVA237 Followed by Placebo     Placebo Followed by NVA237  
STARTED     55     53  
COMPLETED     52     47  
NOT COMPLETED     3     6  
Adverse Event                 3                 4  
Withdrawal by Subject                 0                 2  

Period 2:   Washout (14 - 28 Days)
    NVA237 Followed by Placebo     Placebo Followed by NVA237  
STARTED     52     47  
COMPLETED     49     47  
NOT COMPLETED     3     0  
Adverse Event                 2                 0  
Abnormal Test Procedure                 1                 0  

Period 3:   Period 2 (21 Days)
    NVA237 Followed by Placebo     Placebo Followed by NVA237  
STARTED     49     47  
COMPLETED     49     46  
NOT COMPLETED     0     1  
Protocol Deviation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NVA237 Followed by Placebo

Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.

Period 2: Matching placebo via NEOHALER inhaler device for 21 days

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Placebo Followed by NVA237

Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days

Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Total Total of all reporting groups

Baseline Measures
    NVA237 Followed by Placebo     Placebo Followed by NVA237     Total  
Number of Participants  
[units: participants]
  55     53     108  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 8.50     59.7  ± 8.78     60.5  ± 8.64  
Gender  
[units: participants]
     
Female     25     20     45  
Male     30     33     63  



  Outcome Measures
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1.  Primary:   Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment   [ Time Frame: Day 21 ]

2.  Secondary:   Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment   [ Time Frame: Day 21 ]

3.  Secondary:   Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment   [ Time Frame: Day 21 ]

4.  Secondary:   Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)   [ Time Frame: Day 21 ]

5.  Secondary:   Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)   [ Time Frame: Day 21 ]

6.  Secondary:   Specific Airways Conductance (SGaw)   [ Time Frame: Day 21 ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Specific Airways Conductance (SGaw)
Measure Description

SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.

The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.

Time Frame Day 21  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.

Reporting Groups
  Description
NVA237

Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.

Placebo

Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).

The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.

Salbutamol (albuterol) was used as rescue medication throughout the study.


Measured Values
    NVA237     Placebo  
Number of Participants Analyzed  
[units: participants]
  99     96  
Specific Airways Conductance (SGaw)  
[units: litres/(Second*kpa); kpa = kilopascal]
Least Squares Mean ( 95% Confidence Interval )
   
SGaw at trough, Day 21 (n= 98, 96)     0.48  
  ( 0.45 to 0.51 )  
  0.40  
  ( 0.38 to 0.43 )  
SGaw at peak, Day 21 (n= 97, 96)     0.66  
  ( 0.63 to 0.70 )  
  0.42  
  ( 0.39 to 0.46 )  

No statistical analysis provided for Specific Airways Conductance (SGaw)



7.  Secondary:   Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment   [ Time Frame: Day 21 ]

8.  Secondary:   Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment   [ Time Frame: Day 21 ]

9.  Secondary:   Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1   [ Time Frame: Day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information